Application 076209
- Type
- ANDA
- Sponsor
- AMPHASTAR PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 15MG/ML | No | No |
| 002 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML | No | No |
| 003 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | INJECTABLE; INJECTION | 60MG/2ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0548-9021 | Ketorolac Tromethamine | Ketorolac Tromethamine | Amphastar Pharmaceuticals, Inc. | ANDA | Current |